- Device
- Superion™ Indirect Decompression System (IDS)
- Applicant
- Boston Scientific Neuromodulation
- PMA number
- P140004
- Supplement
- S025
- Product code
- NQO
- Generic name
- Prosthesis, spinous process spacer/plate
- Decision date
- 2021-08-26
- Decision code
- OK30
- Date received
- 2021-07-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Distribute the device incorporating the change as requested in this supplement. This change applies to the final assembly of the Superion Indirect Decompression System (IDS) device. The following manufacturing facility is affected by the change: Boston Scientific Limited, Cashel Rd, ClonmelCo, Tipperary, Ireland.